Cycle development for validated H₂O₂ decontamination processes
Rapid implementation
Short development times and minimal system downtime
Regulatory-compliant execution
In accordance with Annex 1, Section 4.22 i, and USP 1208
Robust methodology
Validated methods and certified biological indicators (6-log)
Precise measurements
Calibrated measurement technology for H₂O₂, temperature, and humidity
System-specific development
Precise adaptation to isolator, loading, and environmental conditions
Flexible options
Optional low-level evaluation <0.003 ppm for H₂O₂-sensitive products
Transparent documentation
Complete audit-ready documentation
Experienced expert team
Highly trained team with extensive hands-on expertise
Application
Validated cycles for your aseptic processes
New isolators and installations
We develop validatable cycles for new isolators from the ground up. This ensures that your installation is regulatory compliant right from commissioning and decontaminates reliably.
Optimization of existing systems
If loading, products, or process conditions change, we tailor existing cycles accordingly. That way you minimize downtime, ensure the sterility of sensitive products, and increase the efficiency of existing installations sustainably.
Use in laboratory environments
We also develop H₂O₂ cycles for R&D or QC laboratories. These cycles guarantee reliable sterility despite changing set-ups, without unnecessarily impeding research and development workflows.
Process
In five steps to a validated decontamination cycle for your isolator
1
Requirements analysis
Clarification of system parameters, loading patterns, and regulatory requirements. Definition of targets for the new or optimized cycle.
2
Test planning
Creation of test documentation (reports, positions, indicators) and coordination with you.
3
Test performance
Multiple test runs on-site on the isolator, under real operating conditions and with biological indicators (BI; geobacillus stearothermophilus) as well as other indicators and tools.
4
Data analysis
Analysis of the results, where necessary adjustment of the cycle parameters (H₂O₂ quantity, reaction time, aeration).
5
Documentation and release
Creation of complete development and test documentation as well as handover to the customer for integration into the qualification documents.
Service highlights
Cycle optimally tailored to your process
Custom-designed cycles
We do not develop standard recipes; instead, we design individual decontamination cycles for your system, precisely tailored to geometry, loading, process environment, and production conditions.
Regulatory assurance
Our cycles comply with Annex 1, Section 4.22 i, and USP <1208>. You receive complete, audit-ready documentation as a basis for qualification and routine operation.
Manufacturer expertise
Our team of experts combines decades of isolator experience with modern measurement technology and professional equipment.
Cycle development for new isolators and systems (with various options)
Option for H₂O₂-sensitive products
Cycle development with H₂O₂ low-level evaluation
Cycle optimization
Cycle optimization for existing systems
Documentation
Development and test documentation
Data
Raw data and BI analysis
For low-level evaluation
Dedicated documentation package
H₂O₂ concentration measurement
Validation with sensors (Dräger or Picarro for low-level evaluation) or Dräger tubes
Temperature and humidity measurement (optional)
Validation with dedicated sensors
Determination of decontamination behavior (optional)
More accurate determination using chemical and/or enzyme indicators
FAQs
The duration depends on the complexity of the isolator and the number of test runs. We plan the workflow so that downtimes are minimized and installations are up and running (again) fast.
Installation and Operational Qualification (IQ/OQ) must be completed in advance, and the cycle requirements must be defined. A fully operational cleanroom, a laminar flow workbench, an incubator, a refrigerator, and an on-site microbiology laboratory are required.
We use certified BIs (Geobacillus stearothermophilus). Their log-6 reduction at all defined positions provides evidence of successful decontamination.
Yes. The cycle development is manufacturer-independent and can be performed on any isolator with an H₂O₂ decontamination system.
We optionally offer a low-level evaluation with a Picarro analyzer that detects concentrations of down to >0.003 ppm. This may require extended aeration times.
Yes, it is normally part of the cycle development but can also be performed as a stand-alone service if requirements change during operation.
